Not yet recruiting NCT06290440
MEdication Counselling Models for Outpatient oRal antIcoaguLation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telepharmacy-led counselling, Pharmacist-led counselling.
- Who it may be relevant to
- Registry conditions: Anticoagulants; Circulating, Hemorrhagic Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development of Medication Counselling Models for Outpatient Oral Anticoagulant-taking Patients
Overview
The goal of this clinical trial is to investigate whether telepharmacy-led counselling can improve medication adherence, knowledge, and hospitalisation/mortality compared with pharmacist-led counselling in adult outpatients taking oral anticoagulants.
Interventions
- Other Telepharmacy-led counselling
The counselling process will be delivered as follows: (1) researchers assist patients in signing up and using the telepharmacy application; (2) researchers send the counselling information from the telepharmacy application to the patient's account (the information will be provided as leaflets and 3-5-minute videos to improve the accessibility); (3) the integrated chatbot system forwards any additional questions or concerns of the patients to the counselling pharmacists; and (4) the pharmacists d - Other Pharmacist-led counselling
Pharmacists will counsel the patients on how to use their OAC. Each counselling section will take approximately 7-15 minutes, depending on the patient's questions or concerns. The counselling contents have already been compiled and validated by NDGD Hospital to ensure rationale and simplicity for every patient. Counselling pharmacists have received specialised training in drug information and patient communication so intervention delivery will be consistent across different pharmacists.
Primary outcome measures
- Medication adherence [Time frame: Measured at month 1, 6, and 12 after randomisation]
Secondary outcome measures (7)
- Knowledge of oral anticoagulants [Time frame: Measured at month 1, 6, and 12 after randomisation]
- All-cause hospitalisation [Time frame: 24 months after randomisation]
- VTE-related hospitalisation [Time frame: 24 months after randomisation]
- Bleeding-related hospitalisation [Time frame: 24 months after randomisation]
- All-cause mortality [Time frame: 24 months after randomisation]
- VTE-related mortality [Time frame: 24 months after randomisation]
- Bleeding-related mortality [Time frame: 24 months after randomisation]
Eligibility criteria
Inclusion criteria
- ≥18 years old
- taking oral anticoagulants
- using smartphones that can access the telepharmacy application
- agreeing to participate
Exclusion criteria
- pregnancy or lactation
- having cancer
- having immunodeficiency disorders or using immunosuppressants
- renal impairment (creatinine clearance <30 mL/min)
- hepatic impairment (Child-Pugh B or C cirrhosis)
- heart failure (class IV, New York Heart Association)
- history of myocardial infarction or stroke within the latest 2 months
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06290440 · 28/NDGD-HDDD